Probitor Normacid 20mg. 14 capsules

What is Probitor Normacid and what it is used
Probitor Normacid contains the active substance omeprazole. It belongs to the group of medicines called "proton pump inhibitors". They act by reducing the amount of acid formed in your stomach.
Probitor Normacid used in adults for the short-term treatment of reflux symptoms (eg. A burning sensation in the chest, back acids into the esophagus).
Reflux is the return of the acid from the stomach into the esophagus, causing inflammation and pain. This can cause symptoms such as pain and burning sensation in the chest, going up to the throat and a sour taste in the mouth (return acids).
You may need to take the capsules for 2-3 consecutive days to get an improvement in symptoms.

2. What you need to know before taking Probitor Normacid
Do not take Probitor Normacid
are allergic (hypersensitivity) to omeprazole or any of the other ingredients of this product, listed in section 6;
if you are allergic to medicines containing other proton pump inhibitors (eg. pantoprazole, lansoprazole, rabeprazole, esomeprazole);
if you are taking a medicine containing nelfinavir (for the treatment of HIV infection).
If you are not sure, talk to your doctor or pharmacist before taking Probitor Normatsid.

Warnings and Precautions
Do not take Probitor Normacid more than 14 days without consulting a doctor. Talk to your doctor if you do not feel better or if your symptoms worsen.

Probitor Normatsid may hide the symptoms of other diseases. Therefore, if any of the following happened to you before you start or while taking Probitor Normatsid, immediately contact your doctor:
if you download a lot of weight for no apparent reason or have difficulty in swallowing;
if you have stomach pain or indigestion;
if you begin to vomit food or blood;
If your stools become black (blood);
If you develop severe or persistent diarrhea, as omeprazole has been associated with a slightly increased incidence of infectious diarrhea;
if you have a stomach ulcer or have undergone surgery of the stomach or intestines;
if you are constantly treatment for indigestion or heartburn of 4 or more weeks;
if 4 or more weeks of continuous complaining of indigestion or acid;
if you have jaundice or severe liver disease;
if you are over 55 years old and your symptoms occur for the first time or have changed recently.
Patients should not take omeprazole as a preventive treatment.

Other medicines and Probitor Normacid
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Probitor Normatsid can affect the way some medicines, and some medicines can affect the action of Probitor Normatsid.
Do not take Probitor Normacid if taking a medicine containing nelfinavir (used to treat HIV infection).
You must necessarily tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots (thrombi)).
Tell your doctor or pharmacist if you are taking the following medicines:
Ketoconazole, itraconazole or voriconazole (used to treat infections caused by fungi);
Digoxin (used to treat heart problems);
Diazepam (used to treat anxiety, muscle relaxant and / or epilepsy);
Phenytoin (used for the treatment of epilepsy). If you are taking phenytoin, you may need a doctor to closely monitor you when you start or stop taking when Probitor Normatsid;
Medicines that thin your blood, such as warfarin or other drugs that block vitamin K may need your doctor may closely monitor you when you start or stop taking when Probitor Normacid;
Rifampicin (used to treat tuberculosis);
Atazanavir (used for the treatment of HTV infection);
Tacrolimus (in cases of organ transplantation);
Yellow wort (Hypericum perforation) (used to treat mild depression);
Cilostazol (used for the treatment of claudication of vascular origin);
Saquinavir (used to treat HIV infection).
Probitor Normacid with food and drink
You can take your capsules with food or on an empty stomach.

Pregnancy and lactation
Before you start taking Probitor Normacid tell your doctor or pharmacist if you are pregnant or planning to become pregnant. Your doctor will decide whether you can take Probitor Normatsid during this time.
Your doctor will decide whether you can take Probitor Normatsid if you are breastfeeding.

Driving and using machines
Not expected Probitor Normacid affect your ability to drive or operate any tools or machinery. Can be side effects, such as dizziness and visual disturbances (see. Point 4). In this case you should not drive or operate machinery.

Probitor Normacid contains lactose
If your doctor has informed you have an intolerance to some sugars, contact him before taking this medicine.

3. How to take Probitor Normacid
Always take Probitor Normacid exactly as written in this leaflet. If you're not sure, ask your doctor or pharmacist.
The usual dosage is one capsule of 20 mg or two capsules of 10 mg once a day for 14 days. Contact your doctor if your symptoms do not disappear after this period.
You may need to take the capsules for 2-3 consecutive days to get an improvement in symptoms.

Taking this medicine
It is recommended to take the capsules morning.
You can take the capsules with meals or on an empty stomach.
Swallow the capsules whole with half a glass of water. Chew or crush the capsules as they contain pellets which are coated so that the drug is not affected by the acid in your stomach. It is important that the pellets are not damaged.
What to do if you have difficulty swallowing capsules
If you have trouble swallowing the capsules:
open the capsule and swallow the contents with half a glass of water or pour the contents into a glass (non-carbonated) water, juice with a sour taste (eg. apples, orange or pineapple) or nectar of apple;
Always shake well the mixture before drinking (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes;
to make sure that you have drunk all of the medication, the glass should be rinsed very well, half filled with water that is drunk. Do not use milk or soda water. Do not chew or crush the solid particles of the drug.
children
This drug should not be used in children and adolescents under 18 years of age.
If you take more than the amount Probitor Normatsid
If you take more than the recommended dose Probitor Normatsid, immediately contact your doctor or pharmacist.

If you forget to take Probitor Normacid
If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose. Do not take a double dose to make up the missed dose.

4. Possible side effects
As with all drugs, Probitor Normacid can cause side effects, although not everyone gets them.

If you notice any of the following rare but serious side effects, stop using Probitor Normatsid and immediately contact a doctor:
sudden wheezing, swelling of the lips, tongue, throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction);
skin redness blistering or peeling. Also can be blistering and bleeding from the lips, eyes, mouth, nose and genitals. This could be "Stevens-Johnson" or "toxic epidermal necrolysis"
yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.
Other side effects include:
Common side effects:
headache;
effects on the stomach or gut: diarrhea, abdominal pain, constipation, flatulence (flatulence);
nausea or vomiting.
Uncommon side effects:
swelling of the feet and ankles;
sleep disorders (insomnia);
dizziness, numbness, "pins and needles" drowsiness;
dizziness (vertigo);
changes in blood tests that show how the liver;
skin rashes, raised rash (hives) and itchy skin;
malaise and lack of energy.
Rare side effects:
blood problems such as reduced numbers of white blood cells or platelets. This can cause weakness, bruising or increased risk of infections;
Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing;
reduction of sodium in the blood. This can cause fatigue, nausea (vomiting) and cramps;
anxiety, confusion or depression;
dysgeusia;
vision problems - such as blurred vision;
sudden onset of shortness of breath or wheezing (bronchospasm);
dry mouth;
inflammation inside the mouth;
infection called "thrush" which can affect the gut and is caused by a fungus;
liver problems, including jaundice - yellowing of the skin, dark urine, and fatigue;
hair loss (alopecia);
skin rashes when exposed to sunlight;
joint pain (arthralgia) or muscle (myalgia);
serious kidney problems (interstitial nephritis);
increased sweating;
inflammatory bowel disease (leading to diarrhea).
Very common side effects:
blood dyscrasias including agranulocytosis (lack of white blood cells);
aggressive behavior;
seeing, feeling or hearing things (hallucinations);
serious liver problems leading to liver failure and brain inflammation;
sudden onset of severe rash or peeling skin or blisters on the skin. This may be associated with fever and arthralgia (erythema multiforme, Stevens-Johnson, toxic epidermal necrolysis);
muscle weakness;
breast enlargement in men;
hypomagnesemia.
In very rare cases Probitor Normacid can affect the white blood cells which cause immune deficiency. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with local infection symptoms such as pain in the neck, throat or mouth, or difficulty urinating, as quickly as possible you should consult your doctor to be able blood tests to exclude the possibility, the number of white blood cells (agranulocytosis). In this case it is important to give information about your medicine.
How to store Probitor Normacid
Keep out of reach of children.
Do not use Probitor Normatsid after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month.
Shelf life of HDPE bottle after opening: 3 months.
Store at a temperature below 25 ° C.
Store in the original container to protect from light and moisture.
Keep container for capsules sealed.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Probitor Normacid
The active substance is omeprazole (omeprazole).
Each hard gastro-resistant capsule contains 20 mg of omeprazole.

The other ingredients are:
Capsule contents: Partially-substituted hydroxypropyl cellulose, microcrystalline cellulose, anhydrous lactose, povidone, polysorbate 80, talc, magnesium oxide, methacrylic acid copolymer dispersion type C, triethyl citrate, magnesium stearate;
Capsule shell:
Cap and body, gelatin, titanium dioxide (E171);
Printing ink: shellac, propylene glycol, ammonium hydroxide, black iron oxide (E172) or shellac, black iron oxide (E172), propylene glycol, concentrated ammonia solution, potassium hydroxide.
Probitor Normatsid looks like and contents of the pack
White cap, white body, each labeled "DME 20" containing beige granules.

Pack sizes:
Blister: 7 and 14 hard gastro-resistant capsules.
White plastic container for capsules with a screw cap, with the closure guaranteeing the integrity of the package and (built-in) desiccant: 7, 10 and 14 hard gastro-resistant capsules.
Not all pack sizes may be marketed.

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